There are several treatment strategies employed to treat acute coronary syndrome (ACS). One is the administration of antithrombotic drugs that prevent and/or dissolve blood clots. Antithrombotics include anticoagulants, antiplatelet agents, thrombolytics and statins. All of these are either used individually or in combination primarily in a prophylactic setting. While some of the drugs are available as oral or sub-cutaneous injections, a majority of these are administered as intra-venous (IV) injections, requiring a hospital or physician office environment is required for drug administration. The need to provide these via an IV route has resulted in some of these drugs like antiplatelet inhibitors and thrombolytics being used only in acute settings, for example, primarily before a Percutaneous Transluminal Coronary Angioplasty (PTCA) or Percutaneous Coronary Intervention (PCI) procedures and/or Coronary Arterial Bypass Graft (CABG) surgery.
There are several treatment strategies employed to treat patients who have undergone mitral and/or other heart valve replacements. One is the administration of antithrombotic drugs that prevent and/or dissolve blood clots. Antithrombotics include anticoagulants, antiplatelet agents, thrombolytics and statins. All of these are either used individually or in combination primarily in a prophylactic setting. While some of the drugs are available as oral or sub-cutaneous injections, a majority of these are administered as intra-venous (IV) injections, requiring a hospital or physician office environment is required for drug administration. The need to provide these via an IV route has resulted in some of these drugs like antiplatelet inhibitors and thrombolytics being used only in acute settings, for example, primarily after a heart valve replacement.
There are several treatment strategies employed to treat acute coronary syndrome (ACS) associated with blockage in the micro capillaries that provide blood to the myocardium. These patients do not qualify for Percutaneous Transluminal Coronary Angioplasty (PTCA) or Percutaneous Coronary Intervention (PCI) procedures and/or Coronary Arterial Bypass Graft (CABG) surgery. These patients are therefore managed by one or more strategies employing antithrombotics and anticoagulants. One is the administration of antithrombotic drugs that prevent and/or dissolve blood clots. Antithrombotics include anticoagulants, antiplatelet agents, thrombolytics and statins. All of these are either used individually or in combination primarily in a prophylactic setting. While some of the drugs are available as oral or sub-cutaneous injections, a majority of these are administered as intra-venous (IV) injections, requiring a hospital or physician office environment is required for drug administration. The need to provide these via an IV route has resulted in some of these drugs like antiplatelet inhibitors and thrombolytics being used only in acute hospital settings.
There are several treatment strategies employed to treat patients who have undergone heart transplant. One is the administration of antithrombotic drugs that prevent and/or dissolve blood clots. Antithrombotics include anticoagulants, antiplatelet agents, thrombolytics and statins. All of these are either used individually or in combination primarily in a prophylactic setting. While some of the drugs are available as oral or sub-cutaneous injections, a majority of these are administered as intra-venous (IV) injections, requiring a hospital or physician office environment is required for drug administration. The need to provide these via an IV route has resulted in some of these drugs like antiplatelet inhibitors and thrombolytics being used only in acute settings, for example, primarily after a heart transplant.
The drug delivery technology limitations have prevented the use of these classes in a chronic setting. The development of antiplatelet inhibitors as oral pills failed clinical testing in humans. The ability to achieve a differentiated PK is important to reducing adverse events that are dose and extent related. Anticoagulants administered via subcutaneous (SC) and oral routes present a high steady state concentration several magnitudes more than the required concentration in the heart as they have to compensate for the routes of delivery.
It is an object of the present invention to provide a non-invasive antiplatelet inhibitor therapy as a prophylactic for ischemic heart conditions associated with the presence of unstable angina (UA), angina, non-ST elevated myocardial infarction (NSTEMI), ST elevated myocardial infarction (STEMI), atrial fibrillation (AF), etc.
It is a further object of the present invention to deliver these drugs directly to the heart and its associated tissues, providing maximum and quick benefit to the regions of the heart where this medication is needed to prevent platelet formation and hence ischemic conditions from recurring.
It is another object of the invention to reduce the exposure of the drug to the rest of the body, thereby reducing associated adverse events such as bleeding.